Omega-3 Fatty Acid Status in Morbid Obesity Before and After Surgical Treatment

Cardiovascular Disease Clinical Trial

Official title:

Omega-3 Fatty Acid Status in Morbid Obesity Before and After Surgical Treatment

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00558532
• Other study ID #: 07-66
• Status: Withdrawn
• Phase: N/A
• First received: November 14, 2007
• Last updated: June 10, 2016
• Start date: October 2007
• Est. completion date: November 2008

Study information

• Verified date: June 2016
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine the concentration of omega-3 fatty acids in plasma, blood and abdominal fat before and after bariatric surgery to provide guidance for future studies.

Description:

The omega-3 fatty acids are essential for human growth, development and well-being. Numerous studies have shown that a relatively high intake of the omega-3 fatty acids are beneficial in brain and visual development, psychiatric disorders, rheumatic disorders, inflammatory responses and cardiovascular disease. As an example, low levels of tissue omega-3 fatty acids are associated with a markedly higher rate of death from cardiac causes compared to patients with relatively high concentrations of the omega-3 fatty acids. Obese patients often have an unhealthy dietary intake and evidence of increased inflammatory processes. After a gastric bypass patients will have decreased absorption of fats from the gastrointestinal tract and may become fatty acid deficient. While gastric bypass may decrease death from cardiovascular disease in morbidly obese patients, cardiovascular disease is still the most common cause of death after a gastric bypass. There are numerous nutritional deficiencies which occur after gastric bypass and many of these are well documented. However, there are no data concerning the plasma and tissue levels of omega-3 fatty acids in morbidly obese patients either before or after operation.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Surgical group candidates must be undergoing surgery for morbid obesity, abdominoplasty or other abdominal operation.

• Must have adequate venous access.

Exclusion Criteria:

• Insufficient venous access

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Fatty Acid Levels
• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

Procedure:
• Bariatric Surgery
Open roux-en-Y gastric bypass, open banded sleeve gastrectomy, abdominoplasty, other abdominal surgery

Locations

Country	Name	City	State
United States	The Christ Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Omega-3 Fatty acid levels in whole blood, plasma and abdominal fat sample		Within 3 months of surgery	No